WO2020148426A1 - Dispositif d'injection - Google Patents

Dispositif d'injection Download PDF

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Publication number
WO2020148426A1
WO2020148426A1 PCT/EP2020/051122 EP2020051122W WO2020148426A1 WO 2020148426 A1 WO2020148426 A1 WO 2020148426A1 EP 2020051122 W EP2020051122 W EP 2020051122W WO 2020148426 A1 WO2020148426 A1 WO 2020148426A1
Authority
WO
WIPO (PCT)
Prior art keywords
dose
dose indicator
injection device
sleeve
housing
Prior art date
Application number
PCT/EP2020/051122
Other languages
English (en)
Inventor
Michael Jugl
Michael Helmer
Steffen Raab
Martin Vitt
Original Assignee
Sanofi
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sanofi filed Critical Sanofi
Priority to CN202080009095.7A priority Critical patent/CN113301931B/zh
Priority to JP2021541257A priority patent/JP2022517805A/ja
Priority to EP20706383.5A priority patent/EP3911383A1/fr
Priority to US17/421,661 priority patent/US20220088313A1/en
Publication of WO2020148426A1 publication Critical patent/WO2020148426A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31566—Means improving security or handling thereof
    • A61M5/3157—Means providing feedback signals when administration is completed
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A61M5/31551—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe including axial movement of dose setting member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/3155—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe
    • A61M5/31553—Mechanically operated dose setting member by rotational movement of dose setting member, e.g. during setting or filling of a syringe without axial movement of dose setting member
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/31556—Accuracy improving means
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/31556—Accuracy improving means
    • A61M5/31558—Accuracy improving means using scaling up or down transmissions, e.g. gearbox
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
    • A61M5/31585—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod performed by axially moving actuator, e.g. an injection button
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/582—Means for facilitating use, e.g. by people with impaired vision by tactile feedback
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/583—Means for facilitating use, e.g. by people with impaired vision by visual feedback
    • A61M2205/585—Means for facilitating use, e.g. by people with impaired vision by visual feedback having magnification means, e.g. magnifying glasses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31533—Dosing mechanisms, i.e. setting a dose
    • A61M5/31545—Setting modes for dosing
    • A61M5/31548—Mechanically operated dose setting member
    • A61M5/31561—Mechanically operated dose setting member using freely adjustable volume steps

Definitions

  • the present invention is generally directed to a handheld injection device, i.e. a drug delivery device for selecting and dispensing a number of user variable doses of a liquid drug or medicament formulation.
  • Pen type drug delivery devices have application where regular injection by persons without formal medical training occurs. This may be increasingly common among patients having diabetes where self-treatment enables such patients to conduct effective management of their disease.
  • a drug delivery device allows a user to individually select and dispense a number of user variable doses of a medicament.
  • so called fixed dose devices which only allow dispensing of a predefined dose without the possibility to increase or decrease the set dose are known.
  • refillable devices i.e., reusable
  • non-refillable i.e., disposable
  • disposable pen delivery devices are supplied as self-contained drug device combinations.
  • self-contained drug device combinations do not have removable pre-filled cartridges. Rather, the pre-filled cartridges cannot be removed or replaced from these devices without destroying or at least causing significant damage to the device.
  • the present invention is applicable for both types of devices, i.e. for disposable devices as well as for reusable devices.
  • a further differentiation of drug delivery device types refers to the drive mechanism: There are devices which are manually driven, e.g. by a user applying a force to an injection button, devices which are driven by a spring or the like and devices which combine these two concepts, i.e. spring assisted devices which still require a user to exert an injection force.
  • the spring-type devices involve springs which are preloaded and springs which are loaded by the user during dose selecting. Some stored-energy devices use a combination of spring preload and additional energy provided by the user, for example during dose setting.
  • the present invention is applicable for all of these types of devices, i.e. for devices with or without a drive spring.
  • a cartridge typically includes a reservoir that is filled with a medicament (e.g., insulin), a movable rubber type bung or stopper located at one end of the cartridge reservoir, and a top having a pierceable rubber seal located at the other, often necked-down, end.
  • a crimped annular metal band is typically used to hold the rubber seal in place. While the cartridge housing may be typically made of plastic, cartridge reservoirs have historically been made of glass.
  • the needle assembly is typically a replaceable double-ended needle assembly. Before an injection, a replaceable double-ended needle assembly is attached to one end of the cartridge assembly, a dose is set, and then the set dose is administered. Such removable needle assemblies may be threaded onto, or pushed (i.e. , snapped) onto the pierceable seal end of the cartridge assembly.
  • the dosing section or dose setting mechanism is typically the portion of the pen device that is used to set (select) a dose.
  • a spindle or lead screw (piston rod) contained within the dose setting mechanism presses against the bung or stopper of the cartridge. This force causes the medicament contained within the cartridge to be injected through an attached needle assembly. After an injection, as generally recommended by most drug delivery device and/or needle assembly manufacturers and suppliers, the needle assembly is removed and discarded.
  • Documents US 5,582,598 and WO 2010/053569 A1 disclose an injection device which comprises a housing and a dose sleeve which provides a groove at its outer surface.
  • the housing comprises a pin which directly meshes with the groove of the dose sleeve.
  • the groove of the dose sleeve comprises sections with different pitch for providing a different dose dialing and dispensing feeling caused by different application forces with regard to each pitch section.
  • the rotation angle with regard to one dose unit is the same for each section of the groove.
  • Document WO 99/38554 A1 refers to an injection syringe comprising a piston rod and a piston rod drive comprising a piston rod guide and a nut member and a dose setting mechanism with a thread connection along which an injection button by rotation of a dose setting element relative to the housing is screwed out from the proximal end of the housing, wherein axial pressing of the injection button transforms the axial movement to a rotation of one of the piston rod drive elements relative to the other.
  • a unidirectional coupling is provided between the nut member and the piston rod guide allowing rotation of these parts relative ot each other in one direction but not in the opposite direction, the allowed rotation being one by which the piston rod is transported in a distal direction in the syringe, the coupling being so designed that a set initial reluctance has to be overcome before the rotation takes place.
  • a click coupling is disclosed providing a moderate resistance against rotation between the housing and the element rotated relative to the housing to set a dose. Thereby it is ensured that the positon corresponding to a set dose is maintained and is not inadvertently altered. The clicks may be taken as an audible signal indicating the size of the set dose.
  • Document US 2012/0046643 A1 describes an injection device for administration of a fixed dose comprising a housing and a dosing element, wherein the user rotates a dosing element in a dose setting direction resulting in a helical movement of the dosing element defined by a position of an engaging feature relative to an inner thread of the housing.
  • the engaging feature By an interaction of the engaging feature with a detent of the thread the user is informed that a dose has been set, wherein the detent gives an audible or tactile signal when the engaging feature passes the detent.
  • Document EP 3 181 171 A1 discloses a drive mechanism for an injection device with a display member and a dose member. Each specific dose size actually set by dialing the display member and the dose member correlates to a well-defined position of blocking elements along a helical path of a blocking structure.
  • an injection device as defined in claim 1.
  • an injection device according to a first principle concept disclosed and explained herein comprises:
  • a dose indicator positioned within the internal space of the housing, the dose indicator having an external surface configured to mesh or engage with the thread feature for restricting the motional freedom of the dose indicator within the housing to follow a helical or screwing movement during dose dialing and dose dispensing, the dose indicator further comprising a number of engaging members at least one thereof being configured to contact the multiple of distinct ratchet features in course of the helical or screwing movement in distinct positions, wherein the contact is configured to provide a user with a tactile indexing appearance in the way of an increased or decreased dwelling torque at each of the multiple distinct positions.
  • the rotation of a dose dial grip coupled to the dose indicator is transferred to the dose indicator such that the dose indicator travels along the helical path, wherein the rotation angle of the dose indicator with regard to an initial position of the dose indicator represents the dialed dose.
  • the engaging member gets in contact with several of the multiple ratchet features, which may be provided as a teething with a plurality of equally spread gear teeth or saw teeth or other form of pointed or rounded teeth.
  • the resolution or pitch of the regular teething may be selected to match with the discrete dose setting positions of the device.
  • one ratchet feature may be provided for every dose increment, for example per unit or half unit of insulin.
  • a reduced set of selectable dose values may be reflected by a respectively reduced number or ratchet features.
  • the advantage of providing the ratchet feature in the large diameter of the housing inner surface can be seen in a very clear indexing perception.
  • the non-overlapping layout of the ratchet features along a unique path of travel provides rich freedom for tailoring the ratchet appearance to the recommended dosing regimen of the respective rug to be expelled.
  • the engaging member may be configured to at least partially disengage from the teething during dose dispensing which helps avoiding torque loss.
  • the device comprises a release mechanism provided in connection with the dose indicator, the release mechanism being configured to, when activated during dose dispense, urge the number of engaging members away from the distant position against the force of the resilient bias thereby suspending the indexing ratchet appearance at least for a subset of the multiple distinct positions.
  • the injection device may have all or some of the ratchet features integrated with the thread feature in the housing, in particular as a profiled a crest line or shoulder of a helically extending thread rib.
  • the engaging member may comprise at least one tooth or cog configured to engage or mate with the ratchet features.
  • the engaging member may be adapted to allow deflection away from this engagement or mating situation. This may be used to configure the mechanism such that the dose indicator provides the indexing appearance only during dose setting or canceling operation. This may be such that the dose indicator is coupled with regard to the housing such that when the dose indicator is rotated during dose dialing the rotational movement is provided in discrete steps only and not continuously, for example in steps covering a full or a half unit of a medicament dose.
  • At least partial disengagement of the engaging member from the ratchet features means that it may be fully disengaged or the engagement may be less strong during dose dispensing (e.g. during dose dispensing the engaging member does not penetrate as deeply as during dose dialing into the notches of the toothing).
  • the partial disengagement may be adapted such that the residual torque loss caused by the ratchet connection is small but the user still slightly feels the engagement.
  • the housing and the dose indicator (dose dial sleeve) of the injection device may have a hollow cylindrical (sleeve-like or tubular) form.
  • the housing and the dose indicator may be threaded to be engaged so that the dose indicator moves helically with regard to the housing during dose dialing and dispensing.
  • a predefined or user selectable dose is dialed by the patient and in the second step the patient dispenses the dialed dose, for example by injection with a needle attached at the distal end of the housing.
  • the fluid medicament is contained within a cartridge attached to the housing or accommodated within the housing.
  • the cartridge comprises a bung at its proximal end which is connected to the distal end of the lead screw (piston rod) such that a distal axial movement of the lead screw drives the bung of the cartridge into distal direction thereby expelling the medicament from the cartridge.
  • the dose injection may be facilitated by a user pressing an injection button which is coupled with the dose indicator.
  • a drive member located within the dose indicator and comprising a first sleeve-like element (also called bushing in the following) which is axially displaceable relative to the dose indicator during dose dispensing,
  • first sleeve-like element of the drive member is adapted to pivot the at least one pivotable engaging member during dose dispensing by an axial displacement relative to the dose indicator in order to at least partly disengage the pivotable engaging member from the toothing of the thread, wherein the first sleeve-like element is displaced against an axial force of a biasing member.
  • This embodiment provides a simple possibility to disengage at least partly the pivotable engaging member from the toothing of the thread.
  • the pivotable engaging member is kept with its proximal end within a notch of a ring comprising a plurality of notches at the inner surface of the dose indicator.
  • the first sleeve-like element may be coaxially accommodated within the dose indicator.
  • the term “during dose dispensing” means the time period in which the injection button is pressed by the user. As soon as the injection button is pressed the first sleeve-like element coupled to the injection button is displaced axially thereby rotationally coupling the dose indicator and the first sleeve-like element.
  • the biasing member may be a compression spring or at least one Belleville spring washer.
  • the first sleeve-like element comprises longitudinal grooves, for example at its distal end, which engage projecting teeth provided at the inner surface of the dose indicator during dose dispensing in order to be rotationally fixed with regard to the dose indicator and thereby rotate together with the dose indicator during dose dispense.
  • the dose indicator rotates relative to the first sleeve-like element during dose dialing.
  • the first sleeve-like element is coupled to a lead screw, wherein the lead screw does neither rotate nor translate axially during dose dialing.
  • the first sleeve like element is coupled to the lead screw via a second sleeve-like element, wherein the second sleeve-like element and the lead screw are coupled by a splined connection, for example a pin moving along a groove running in axial (longitudinal) direction.
  • the second sleeve-like element does neither rotate nor translate during dose dialing, wherein the first sleeve-like element translates axially relative to the second sleeve-like element during dose dialing.
  • the first sleeve-like element and the second sleeve-like element together may form a drive member.
  • the dose indicator further comprises at least one second pivotable member, wherein the at least one second pivotable member may be located, for example, essentially opposite to one pivotable engaging member or two pivotable engaging members with regard to the cross section of the dose indicator, wherein the second pivotable member is adapted to support the first sleeve-like element during axial displacement of the first sleeve-like element relative to the dose indicator. This support avoids a rocking movement of the first sleeve-like element or its jamming within the dose indicator.
  • the second pivotable member may be kept with its proximal end within the notch of a ring comprising a plurality of notches/grooves and teeth (between the notches/grooves) at the inner surface of the dose indicator.
  • the at least one pivotable engaging member has a suitable and wing-like form, which is easy and cost effective in production, wherein the wing-like form comprises at least one of the following features:
  • the wing-like form is attached to the dose indicator by a neck portion, wherein a pivot axis may be located at the neck portion,
  • a side surface of the wing-like form oriented radially outwards is adapted to engage the toothing of the thread
  • a sloping surface at the proximal end of the wing-like form is adapted such that a
  • the side surface of the wing-like form comprises a tooth or cog wherein the tooth or cog projects from the side surface and/or is adapted to engage the toothing of the thread.
  • the toothing of the thread comprises a first section with a first profile form and a second section with a second profile form, wherein the first profile form is different from the second profile form.
  • the thickness of each tooth or the pitch i.e. the thickness of one tooth and the width of one neighboring groove
  • each measured along the thread, or the form of the teeth or the grooves is different in the first section and the second section.
  • the height of each tooth is different in the first section and the second section.
  • the toothing may be tailored to the needs of the patient and/or the injection device in an easy and cost effective way.
  • the toothing may be adapted such that it allows tactile engagement only in a predefined section of the thread thereby indicating to the user that only medicament doses corresponding to the predefined section of the thread are allowed to be dialed.
  • a drive member may effect a change in the transformation ratio between the rotation and the longitudinal shift of the dose indicator relative to the housing such that within a first rotation angle section the rotation of the dose indicator is transformed with a first transformation ratio and within at least a second rotation angle section the rotation of the dose indicator is transformed with a second transformation ratio, wherein the (absolute) rotation angle of the dose indicator is measured from an initial position of the dose indicator.
  • the drive member of the injection device provides a change in the conversion ratio when the dose indicator is rotated within a second rotation angle section measured from the initial position of the dose indicator compared with the first rotation angle section.
  • the initial position is the zero dose position which is taken by the dose indicator prior dose dialing.
  • the transformation ratio change provides the possibility to dial the dose within a first rotation angle section with a different resolution (higher or smaller) than in a second rotation angle section.
  • the transformation change also occurs during dose dispensing (injection) but vice versa.
  • the rotation angle is the absolute rotation angle which may be higher than 360°.
  • the first rotation angle section refers to smaller rotation angles than the second rotation angle section.
  • the first rotation angle section is from the initial position until a rotation angle of 360° of the dose indicator and the second rotation angle section is from a rotation angle of 360° to 720° or 1080° of the dose indicator.
  • the transformation ratio is identical. The transformation ratio suddenly changes from the first transformation ratio to the second transformation ratio during dose dialing and reverse during dose injection but stays the same within one predefined rotation angle section.
  • the first transformation ratio is less than the second transformation ratio, for example the first transformation ratio is 1 U / 1 and the second transformation ratio is 1 U / 2 ⁇ , wherein 1 U means one revolution of the dose indicator with regard to the housing and I means a predefined length value (unit of length) of the longitudinal (axial) shift of the dose indicator with regard to the housing, wherein 2 ⁇ means 2 times I.
  • the rotation velocity of the dose indicator within the first rotation angle section and the second rotation angle section is identical or approximately identical. This is because the threaded connection of the dose indicator with regard to the housing has the same lead within the first rotation angle section and the second rotation angle section of the dose indicator.
  • the dose indicator may be rotatably fixed during dose dispense with regard to the first sleeve-like element of the drive member, wherein the drive member may further comprise the second sleeve-like element positioned within the first sleeve-like element, wherein the second sleeve-like element (also called driver tube in the following) may be coupled to the lead screw, and wherein the first sleeve-like element may be coupled to the second sleeve-like element by means of a connection comprising a pin and a groove, wherein the pin may move along the groove during dose dialing and dose dispensing.
  • the first sleeve-like element and the second sleeve-like element may be tubular elements.
  • the second sleeve-like element may be rotatably fixed with regard to the housing during dose dialing and rotatable with regard to the housing during dose dispensing.
  • the groove may provide a first pitch (grade, slope) along a first section of the groove and a second pitch (grade, slope) along a second section of the groove, wherein the first pitch may be different from the second pitch.
  • the first section of the groove may correspond to the first rotation angle section of the dose indicator and the second section of the groove corresponds to the second rotation angle section of the dose indicator.
  • the first pitch may be higher than the second pitch, for example, the first pitch may be twice the second pitch.
  • the first pitch may be 45° and the second pitch may be 0° meaning the groove running in parallel to the longitudinal axis of the injection device and the first sleeve-like element or the second sleeve-like element providing the groove.
  • the two elements forming the drive member coupled with a pin-groove connection may be found to provide a cost effective possibility to realize the present concept. If one needs a certain relation with regard to the first and the second transformation ratio, mainly the construction of these two elements needs to be changed with regard to the new relation. A fully new construction of the whole injection device is not necessary.
  • the pin- groove connection between the first sleeve-like element and the second sleeve-like element may be realized such that the first sleeve-like element comprises at least one projecting pin at its inner surface, wherein the second sleeve-like element comprises the same number of grooves at its outer surface.
  • the first sleeve-like element may comprise the groove and the second sleeve-like element may comprise the pin.
  • the dose indicator comprises a scale at its surface showing the dialed dose to the user, preferably through a window or opening within the housing.
  • the scale may be a marking provided along a helical path at the surface of the dose indicator, for example by means printing or laser engraving.
  • the scale may comprise a first scale section corresponding to the first rotation angle section and a second scale section corresponding to the second rotation angle section of the dose indicator, wherein the graduation of the first scale section may be different from the graduation of the second angle section.
  • the graduation of the first and the second scale section may correspond to the resolution during dose dialing and dispensing within the respective rotation angle section.
  • the number of scale sections may correspond to the number of rotation angle sections provided by a specific implementation.
  • the lead screw may be rotatable coupled with the housing during dose dispensing and axially and rotatably fixed with regard to the housing during dose dialing.
  • the injection device comprises a injection button coupled to the dose indicator at its proximal end, wherein the injection button is adapted to be pressed into distal direction for dose dispensing thereby axially displacing the first sleeve-like relative to the dose indicator.
  • the injection device may comprise a cartridge containing a liquid drug or medicament. In instances, by pressing the injection button a portion thereof may be expelled from the cartridge according to the dialled or pre-set amount.
  • the terms“drug” and“medicament”, may refer to a pharmaceutical formulation containing at least one pharmaceutically active compound. More details on particular pharmaceutical formulations may be taken from the disclosure of the co-pending application PCT/EP2018/082640 which, to this extent, shall be included herein by reference.
  • the injection device may be configured to deliver variable, user- selectable, doses of medicament from a cartridge, via a needle.
  • the device is disposable. It is delivered to the user in a fully assembled condition ready for first use.
  • a dose may be set by rotating the dial grip located at the end of the housing and coupled to the dose indicator. Delivery of a dose may be initiated by pressing the injection button and displacing the injection button axially in the distal direction. Dose delivery may continue while the injection button remains depressed, until the complete set dose has been delivered.
  • the mechanism may provide audible, visual and/or tactile feedback both on the setting and delivery of each dose.
  • Figure 1A shows a side view of a first embodiment of an injection device with a cap
  • Figure 1 B shows a side view of the injection device of Figure 1 without cap
  • Figure 2 shows an exploded view of the components of the injection device of Figure 1 ;
  • Figure 2A depicts a longitudinal section of the proximal end of the injection device of Figure 1 during dose dialing;
  • Figure 2B shows a cross section of the injection device of Figure 1 during dose dialing
  • Figure 2C shows an enlarged section of Figure 2A
  • Figure 2D depicts a longitudinal section of the proximal end of the injection device of
  • Figure 2E shows a cross section of the injection device of Figure 1 during dose
  • Figure 3 shows a cross section of the drive member of the injection device of a second embodiment of an injection device (see A-A in Figure 4);
  • Figure 4 depicts a partly cut away side view of the drive member of Figure 3; and Figure 5 shows the unrolled surface of one element of the drive member of Figure 3.
  • Figures 1A and 1 B show a first embodiment of an injection device (drug delivery device) in the form of an injection pen.
  • the device has a distal end (lower end in Figures 1A and 1 B) and a proximal end (upper end in Figures 1A and 1 B).
  • the component parts of the injection device are shown in Figure 2. All components are located concentrically about a common principal axis (longitudinal axis) of the mechanism.
  • the drug delivery device comprises a body or housing 1 , a cartridge holder 2, a cartridge 3, a cap 4, a lead screw (piston rod) 6, an insert 40, a drive member which is a unit consisting of two elements, namely a bushing (first sleeve-like element) 82 and a driver tube (second sleeve-like element) 85, a dose indicator (number sleeve) 80, a dial grip 81 , and an injection button 88.
  • a drive member which is a unit consisting of two elements, namely a bushing (first sleeve-like element) 82 and a driver tube (second sleeve-like element) 85, a dose indicator (number sleeve) 80, a dial grip 81 , and an injection button 88.
  • a needle arrangement (not shown) with a needle hub and a needle cover may be provided as additional components, which can be exchanged as explained above.
  • the removable cap 4 fits over the cartridge holder 2 and is retained via clip features to the cartridge holder 2 or the housing 1 (see Figure 1A).
  • the housing 1 is a generally tubular component which provides location for the liquid medication cartridge 3 and the cartridge holder 2 which is attached to the housing 1 or integral with it.
  • the cartridge holder 2 receives cartridge 3.
  • a slot or window 2a is provided through which the cartridge 3 can be viewed.
  • One window (through going opening) 18 is provided extending in the longitudinal direction of the housing 1. Through window 18 the dose number N of a scale provided on the outer surface of the dose indicator 80 can be viewed.
  • the window 18 may be covered by a transparent layer or may comprise a transparent lens in order to magnify the shown dose number N.
  • the lead screw 6 has an external thread 7 and is rotationally constrained to driver tube 85 via a splined interface. When rotated, the lead screw 6 is forced to move axially relative to the housing 1 , through its threaded interface with the insert 40 using thread 7 of the lead screw 6. The lead screw 6 acts on a bung within the liquid medicament cartridge 3 such that the medicament is driven out of the cartridge 3.
  • the insert 40 is axially and rotationally fixedly attached to the housing 1 , for example within the distal end of the housing 1.
  • the bushing 82 has, for example, two pins 101 projecting from its inner wall engaging grooves 100 of the driver tube 85 whereby the bushing 82 and the driver tube 85 are coupled to each other so that rotation is transmitted between said two elements based on the form of the groove 100 as explained in detail below. Providing only one pin 101 or three or more pins 101 is possible as well.
  • the driver tube 85 is a tubular element which comprises, for example, two grooves 100 running in axial (longitudinal) direction at its outer surface.
  • the number of grooves 100 corresponds to the number of pins 101 of the bushing 82.
  • the dial grip 81 is splined to the dose indicator 80, for example by teeth, when in the dialing condition.
  • the dial grip 81 is one-piece with the dose indicator 80, for example formed by injection molding.
  • the motional freedom between the dose indicator 80 and the housing 1 is constrained to follow a helical or screwing movement. This is achieved by corresponding mechanical features provided on the dose indicator 80 on one hand side and the inner surface 11 of the housing 1 on the other hand side that mate to form a threaded connection.
  • the inner surface of the housing is provided with a thread feature in the way of an extended helical rib 12.
  • the corresponding configuration on the dose indicator for mating with the tread feature on the housing inner surface 11 is a helical groove 79, located at the outer surface of the dose indicator 80.
  • the helical path 79 may have rotational hard stops (not shown) at the respective ends forming a zero dose abutment and a maximum dose abutment for the dose dialed within one dialing step.
  • the dose indicator 80 is marked with a sequence of numbers N in form of a scale at its outer surface, which are visible through the window 18 in the housing 1 , to denote the dialed dose of medicament.
  • the injection button 88 may be formed a plate-like element which is rotatably mounted with a pivot pin 94 journaled in an end wall of the bushing 82.
  • the injection button 88 is rotatably coupled to the bushing 82 by means of a bearing 95, for example, a ball bearing.
  • a bearing 95 for example, a ball bearing.
  • the injection button 88 moves axially together with the bushing 82 in proximal direction.
  • the button 88 is pressed by the user’s finger axially in distal direction and moves driven by the force of the user's finger into the distal direction and does not rotate, wherein the bushing 82 rotates together with the dose indicator 80, the driver tube 85 and the lead screw 6 helically with respect to the housing 1.
  • the bearing 95 allows the rotation of the bushing 82 relative to the injection button 88.
  • the crest line 12a of the projecting helical thread 12 comprises at least along a predefined section a toothing 112, for example gear teeth or saw teeth.
  • a toothing 112 for example gear teeth or saw teeth.
  • Other pointed or rounded toothing forms are possible, as well.
  • the teething is of a regular kind in the sense that the teeth or features are placed adjacently and without suspension, for example by intermittent un-contoured regions.
  • the purpose of the teething 112 is to provide a mechanical interface with a multiple of distinct ratchet features that serve for contact areas in an interacting or meshing engangement with one or more engaging members located in essentially fixed relation to the dose indicator 80.
  • This engagement in general, is configured to cause a modulation in the dwell torque or frictional counter torque it acts against a relative rotation of the dose indicator 80 and the housing 1.
  • the modulation at a distinct position, may be in the way of an increase or decrease in the dwell torque that promotes or counteracts a user induced rotation of the aforementioned parts.
  • the perception of the modulation can provide a user with a tactile indexing feedback.
  • the indexing feedback may be such that it allows the user to understand where distinct preferred dialing positions are located.
  • the feedback may be rather designed to give the user a tactile impression when performing a stepwise increase or decrease in dose dialing.
  • the feedback may be provided for convenience reasons but, in instances, the feedback may also be designed to increase safety.
  • an appropriately defined dose increment overhaul torque may help to prevent unintended changes in dose setting.
  • Unintended dose setting changes could be cause by incautious handling of the dialed injection device during subsequent steps before drug administration. It is not hard to imagine that unexperienced users might touch the injection device at the dose indicator 80 when screwing a needle (not shown) onto the flange, namely thread 5.
  • perceivable indexing appearance requires some torque input. It might therefore be a consideration to provide switchable indexing appearance. This may help to reduce an indexing caused loss in torque output during dose delivery.
  • the torque required for rotating the lead screw has to be created by conversion of the linear user input force along the threaded engagement between the dose indicator and the housing.
  • switching of the indexing is achieved by means of one engaging member 84a which is pivotable hinged to the dose indicator 80 in a live hinge or similar bendable structure.
  • the live hinge is configured to provide a biasing force to the engaging member 84a in a radially outward direction.
  • This biasing is configured to urge the engaging member 84a into engagement with a teeth (cog) of the teething 112. Accordingly, this contact occurs at the side surface 184a of the engaging member 84 which is oriented radially outwards against the crest line of the teething 112 of the thread 12.
  • the engaging member 84a is attached by a neck portion 284a located at the distal end of the engaging member 84a to the dose indicator 80, wherein the neck portion 284a is, for example, pivotably attached to a front surface of a distal end flange of the dose indicator 80 as shown in Figures 2A, 2C and 2D.
  • the engaging member 84a has a wing-like form with a proximal end and a sloping surface 384a extending from the proximal end of the wing-like form.
  • the dose indicator 80 further comprises at least one second pivotable member 84b which is located, as shown, radially opposite to the slider member 84a.
  • the slider member 84b has a wing-like form
  • the slider member 84b does not engage with the teething 112 of the thread 12 but rather abuts against a cylindrically shaped portion of the inner surface 11.
  • the contact region of the slider member 84b may be provided as a slightly rounded side surface 184b projecting radially outwards. This is shown in Figures 2A to 2C.
  • the slider member 84b is expected to produce approximately the opposite radial reaction force to the dose indicator 80 as the engaging member 84a produces to thereby maintain the dose indicator 80 in a center axis balanced force situation.
  • the second pivotable member 84b is attached to the front surface of the distal end flange of the dose indicator 80 by a second live hinge 284b.
  • Both, namely the engaging member 84a and the slider member 84b have tapered rounded heads defining protruding distally into the interior space of a teethed bore 86 in the dose indicator 80.
  • the rounded heads define two radially outward facing sloping surfaces 384a, 384b that allow contact of a tapered surface to deflect the members 84a, 84b radially inwards.
  • the dose indicator 80 comprises a compression spring 89 located between the front surface of the distal end flange of the dose indicator 80 at its distal end and an opposite distal front surface of the bushing 82 and presses the flange 83 of the bushing 82 and/or an outer flange 88a of the injection button 88 against a flange 80a projecting from the inner surface of the dial grip 81 or the dose indicator 80.
  • a biasing element for example at least two Belleville spring washer, may be provided between a flange 80b at the housing (see Figures 2A and 2D) and the flange 83 of the bushing 82 (not shown).
  • the bushing 82 comprises at its distal end a sloping surface 82a forming a cone-like surface (see Figure 2C). Further, the outer surface of the bushing 82 comprises at its distal end longitudinal grooves 82b (see Figures 2C and 2D).
  • the dose indicator 80 With the device in the "at rest” condition, the dose indicator 80 is positioned at its initial position, for example with its zero dose abutment against the zero dose abutment of the housing 1 and the injection button 88 is not depressed, i.e. in the position shown in Figure 1A. Dose marking (number) 'O' on the dose indicator 80 is visible through the window 18 of the housing 1.
  • the user selects a variable dose of the medicament by rotating the dial grip 81 clockwise, which generates an identical rotation of the dose indicator 80 by the connection to the housing 1 via thread 12 and helical path 79.
  • each projecting pin 101 of the bushing 82 translates along the respective longitudinal groove 100 of the driver tube 85 into proximal direction taken along by the axial force of the compression spring 89, wherein the driver tube 85 is locked against clockwise rotation by radial protrusions at a clicker arm 85a which are biased toward the inner side wall of the insert 40.
  • the driver tube 85 nor the lead screw 6 undergo any type of motion relative to the housing during dose dialing.
  • the cog or tooth on the side surface 184a of the pivotable engaging member 84a of the dose indicator 80 clicks from one recess between two of the teeth of the teething 112 at the thread 12 to the next one, the recesses may be so spaced that one click corresponds to a pre-defined change of the set dose, e.g. one unit or one half unit.
  • the dose indicator 80 rotates relative to the housing 1 by one recess.
  • the protrusion cog or tooth on the side surface 184 of the engaging member 84a
  • an audible click may be generated by the tooth overhaul, and tactile feedback is given by the change in torque input.
  • the user may further increase the selected dose by continuing to rotate the dial grip 81 in the clockwise direction.
  • the process of overhauling the teeth of the teething 112 is repeated for each dose increment. If the user continues to increase the selected dose until the maximum dose limit for one selected medicament dose (not shown) is reached, the dose indicator 80 may reach the maximum dose abutment when provided on the housing 1 and thereby prevent further rotation of the dose indicator 80 in this direction.
  • the compression spring 89 may be attached to the dose indicator 80 and slides with its proximal end along the distal front surface of the bushing 82 during dose dialing.
  • the compression spring 89 is attached to the bushing 82 and slides along the dose indicator 80 during dose dialing. It is a purpose of the compression spring 89 to maintain the bushing 82 in a distally retracted position relative to the dose indicator 80 wherein no engagement of the internal teeth 86 in the bore of the dose indicator 80 and on the external teeth 82b on bushing occurs and the dose indicator 80 is allowed to rotate without driving the bushing 82. With the mechanism in a state in which a dose has been selected, the user is able to deselect any number of increments from this dose. Deselecting a dose is achieved by the user rotating the dial grip 81 anti-clockwise.
  • a splined connection is created between the dose indicator 80 and the bushing 82 to cause the bushing 82 for rotating together with the dose indicator 80.
  • the splined connection is provided by the grooves 82b of the bushing 82 engaging the teeth between two neighboring grooves 86 at the inner wall of the dose indicator 89 (see Figure 2D).
  • the spring 89 may be configured such as to allow engagement of the splined connection before the dose indicator 80 starts rotating.
  • the forces may be arranged such as to create the above locking effect only in a position of the dose indicator 80 where a ratchet feature 112 engagement occurs. In the intermittent positions the dose indicator 80 would be driven towards the next ratchet feature 112 engagement without driving the bushing 82 to this extent. At the ratchet feature engagement, the mechanism would behave as explained before, namely by engaging the splined connection between dose indicator 80 and bushing 82 before subsequent rotation takes place.
  • the injection button 88 By pressing the injection button 88 the injection button 88 and with it the bushing 82 move into distal direction relative to the dose indicator 80 against the force of the compression spring 89 until the flange 83 of the bushing and/or the flange 88a of the injection button 88 abuts the second flange 80b of the dose indicator 80 (see Figure 2D).
  • the engaging member 84a and the slider member 84b are deflected radially inwards by abutment of the sloping surface 82a of the bushing 82 against the sloping surfaces 384a, 384b of the engaging member 84a and the slider member 84b.
  • the deflection of the engaging member 84a causes disengagement of the engaging member 84 from the teething 112.
  • the slider member 84b is deflected, as well, thereby maintaining the balance in reaction forces on the bushing 82 and thereby avoiding creation of any tilting torque on the bushing 82 relative to the dose indicator 80 (see Figures 2D and 2E).
  • the deflection axis are configured to extend, for example, essentially perpendicular to the longitudinal axis of the injection device.
  • the displacement of the bushing 82 into distal direction causes an engagement of the grooves 82b at the outer surface of the bushing 82 and the teeth forming the grooves 86 at the inner surface of the dose indicator 80 thereby coupling the dose indicator 80 and the bushing 82 so that both elements rotate together.
  • the longitudinal force necessary to compress the compression spring 89 is configured such that first the grooves 82b at the outer surface of the bushing 82 engage the teeth forming the grooves 86 at the inner surface of the dose indicator 80 and after engagement the longitudinal force provided by the user to the injection button 88 is transmitted via the dose indicator 80, the bushing 82, the driver tube 85 to the lead screw 6 in order to inject the dialed medicament dose.
  • Tactile feedback during dose dispense may be provided via compliant cantilever clicker arm 85a integrated into the distal end of the driver tube 85 as shown in Figure 2.
  • This arm85a interfaces radially with ratchet features on the inner surface of the insert 40, whereby the ratchet tooth spacing corresponds to the dose indicator 80 rotation required for a single increment dispense.
  • the ratchet feature engages with the clicker arm 85a to produce an audible click with each dose increment delivered.
  • the clicker arm 85a is further adapted such that it prevents rotation of the lead screw during dose dialing.
  • Delivery of a dose continues via the mechanical interactions described above while the user continues to depress the injection button 88. If the user releases the injection button 88, the delivery of a dose is halted.
  • the user may release the injection button 88.
  • the mechanism is now returned to the“at rest” condition, in particular the dose indicator 80 is returned to its initial position (zero position, see Figure 1A).
  • each groove 100 of the driver tube 85 has a first section 100a at its distal end and a second section 100b at its proximal end, wherein the second section 100b is a straight groove traveling parallel to the longitudinal axis of the device.
  • the first section 100a of the groove 100 is a helical groove providing a half revolution with the same handedness as a helical path 79 of the dose indicator 80.
  • the helical path 79 of the dose indicator 80 and the first section 100a of the groove 100 both are left-handed.
  • the groove 100 forms a two-start-thread but a one-start-thread or a three-start-thread is possible as well depending on the number of pins 101 of the bushing 82.
  • the second embodiment of the injection device comprises a scale with numbers N having a first section 99a of the scale covering the numbers 0 to 19 and a second section 99b of the scale covering the numbers 20 to 100.
  • the numbers of the first section of the scale are shown through window 18 of the housing 1 during the first revolution of the dose indicator 80 (i.e. the first 360° of the rotation, the first rotation angle section) and the numbers of the second section of the scale are shown during the second and the third revolution of the dose indicator 80 (i.e. >360° to 1080° of the rotation, the second rotation angle section). Accordingly, during the first rotation angle section of the dose indicator 80 the dose can be dialed with the double resolution compared with the second rotation angle section of the dose indicator 80.
  • each projecting pin 101 of the bushing 82 translates along the respective longitudinal groove 100 of the driver tube 85 into proximal direction taken along by the projecting flange 83, wherein the groove 100 comprises the first section 100a and the second section 100b.
  • the pitch of the first groove section 100a is approximately 45°, whereas the pitch of the second groove section 100b is 0°.
  • the full revolution of the dose indicator 80 is transformed into a half revolution of the bushing 82 backwards caused by the helical groove section 100a and the axial (helical) translation of the dose indicator 80 with the length I/2 compared with the lead I of the helical thread 79 of the dose indicator 80.
  • the first helical groove section 100a thereby provides a loss angle of 180° or a half revolution (see Figure 3). Accordingly, the transformation ratio increases from the first rotation angle section to the second rotation angle section. This allows a higher resolution for dose dialing during the first rotation angle section of - in this embodiment - 360° using the dose indicator 80.
  • the numbers N of the first scale section 99a are shown within window 18.
  • each pin 101 arrives at the second section 100b of the groove 100.
  • the bushing 82 is kept non-rotated with regard to the driver tube 85 due to its coupling to the driver tube 85 by the straight axial second section 100b of the groove 100.
  • the axial (helical) translation of the dose indicator corresponds to the lead I of the helical thread 79 of the dose indicator 80.
  • the resolution for dose dialing is half of the resolution provided during the first rotation angle section of the dose indicator 80.
  • the numbers N of the second scale section 99b are shown within window 18.
  • each pin 101 travels along its corresponding groove 100 into opposite (distal) direction compared with dose dialing. Accordingly, when passing the first groove section 100a only half of the dose per one revolution is dispensed due to the helical form of the groove compared with the second groove section 100b.
  • the inner toothing at the insert 40 has smaller teeth with a pitch of half of the pitch in the first embodiment explained above.
  • the ratchet teething at the insert is thereby able to match with the increased resolution of the mechanism during high-resolution dose expelling, namely when the pin 101 travels along the helical first section 100a of the groove 100.
  • the form of the teething 112 of the thread 12 may be adapted to a different dose amount per rotation angle of the dial grip 81 or different mechanism behavior at different rotation angle. Accordingly, the teeth form may be adapted to the dialed (and dispensed) dose for each (absolute) rotation angle section. This adequate feedback improves dose dialing for the user.

Abstract

L'invention concerne un dispositif d'injection comprenant - un boîtier (1) définissant un espace interne ayant une surface interne (11), la surface interne (11) étant dotée d'un élément de filetage (12) et d'un multiple d'éléments de cliquet distincts (112) s'étendant le long d'un trajet hélicoïdal, - un indicateur de dose (80) positionné dans l'espace interne du boîtier (1), l'indicateur de dose (80) ayant une surface externe configurée pour s'engrener ou être en prise avec l'élément de filetage (12) afin de restreindre la liberté de mouvement de l'indicateur de dose (80) dans le boîtier (1) pour suivre un mouvement hélicoïdal ou de vissage pendant la sélection de dose et la distribution de dose, l'indicateur de dose (80) comprenant en outre un certain nombre d'éléments de mise en prise (84a) dont au moins un est configuré pour entrer en contact avec le multiple d'éléments de cliquet distincts (112) pendant le mouvement hélicoïdal ou de vissage dans des positions distinctes, le contact étant configuré pour fournir à un utilisateur un aspect d'indexation tactile à la manière d'un couple de logement accru ou réduit dans chacune des multiples positions distinctes, comprenant en outre un mécanisme de libération (82, 85) qui est placé en raccordement avec l'indicateur de dose (80), le mécanisme de libération (82, 85) étant configuré, lorsqu'il est activé pendant la distribution de dose, pour solliciter le nombre d'éléments de mise en prise (84a) à l'opposé de la position distante contre la force de la sollicitation élastique, ce qui permet de suspendre l'aspect de cliquet d'indexation au moins pour un sous-ensemble des multiples positions distinctes.
PCT/EP2020/051122 2019-01-18 2020-01-17 Dispositif d'injection WO2020148426A1 (fr)

Priority Applications (4)

Application Number Priority Date Filing Date Title
CN202080009095.7A CN113301931B (zh) 2019-01-18 2020-01-17 注射装置
JP2021541257A JP2022517805A (ja) 2019-01-18 2020-01-17 注射デバイス
EP20706383.5A EP3911383A1 (fr) 2019-01-18 2020-01-17 Dispositif d'injection
US17/421,661 US20220088313A1 (en) 2019-01-18 2020-01-17 Injection Device

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP19305066.3 2019-01-18
EP19305066 2019-01-18

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WO2020148426A1 true WO2020148426A1 (fr) 2020-07-23

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PCT/EP2020/051122 WO2020148426A1 (fr) 2019-01-18 2020-01-17 Dispositif d'injection

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US (1) US20220088313A1 (fr)
EP (1) EP3911383A1 (fr)
JP (1) JP2022517805A (fr)
CN (1) CN113301931B (fr)
WO (1) WO2020148426A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5582598A (en) 1994-09-19 1996-12-10 Becton Dickinson And Company Medication delivery pen with variable increment dose scale
WO1999038554A1 (fr) 1998-01-30 1999-08-05 Novo Nordisk A/S Seringue d'injection
WO2010053569A1 (fr) 2008-11-07 2010-05-14 Becton, Dickinson And Company Stylet d'injection pour injection intradermique d'un médicament
US20120046643A1 (en) 2008-12-23 2012-02-23 Sanofi-Aventis Deutschland Gmbh Injection device
EP3181171A1 (fr) 2015-12-14 2017-06-21 Sanofi-Aventis Deutschland GmbH Mécanisme d'entraînement pour dispositif d'injection

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP5545506B2 (ja) * 2012-10-27 2014-07-09 裕史 松本 ペン型注射器
DK2983759T3 (en) * 2013-04-10 2018-02-12 Sanofi Sa INJECTION DEVICE
AR102190A1 (es) * 2014-10-09 2017-02-08 Sanofi Sa Dispositivo de administración de fármacos
JP2017535360A (ja) * 2014-11-24 2017-11-30 サノフイ 可変用量薬物送達デバイスに薬剤の最大用量を設定するための機構

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5582598A (en) 1994-09-19 1996-12-10 Becton Dickinson And Company Medication delivery pen with variable increment dose scale
WO1999038554A1 (fr) 1998-01-30 1999-08-05 Novo Nordisk A/S Seringue d'injection
WO2010053569A1 (fr) 2008-11-07 2010-05-14 Becton, Dickinson And Company Stylet d'injection pour injection intradermique d'un médicament
US20120046643A1 (en) 2008-12-23 2012-02-23 Sanofi-Aventis Deutschland Gmbh Injection device
EP3181171A1 (fr) 2015-12-14 2017-06-21 Sanofi-Aventis Deutschland GmbH Mécanisme d'entraînement pour dispositif d'injection

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CN113301931B (zh) 2024-05-03
JP2022517805A (ja) 2022-03-10
EP3911383A1 (fr) 2021-11-24
CN113301931A (zh) 2021-08-24
US20220088313A1 (en) 2022-03-24

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